NCT00504582

Fibrin Melanoma Axillary Node Study in Patients With Melanoma

Completed NA Results posted Last updated 9 May 2023

What this trial tests

NA trial testing Fibrin Sealant in Melanoma in 121 participants. Completed in 9 April 2020.

Timeline

15 May 2002

Primary endpoint
9 April 2020

9 April 2020

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	121
Start date	15 May 2002
Primary completion	9 April 2020
Estimated completion	9 April 2020
Sites	1 location across United States

Drugs / interventions tested

• Fibrin Sealant — full drug profile →

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Drain Duration Primary · from surgery until drain removed, up to 40 days

Number of days drain was in place

Group	Value	95% CI
Treatment Arm	23	7 – 40
Control Arm	21	5 – 36

Number of Participants With Infection Secondary · after surgery until the wound is healed, up to 30 days whichever is longer

Number of participants with any signs of infection noted following surgery requiring intervention.

Group	Value	95% CI
Treatment Arm	12
Control Arm	8
Questionnaire Only	0

Adverse events — posted to ClinicalTrials.gov

Time frame: After surgery until the wound is healed or thirty days whichever is longer.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm

Serious: 2/47 (4%)

Deaths: 0/47

Control Arm

Serious: 1/45 (2%)

Deaths: 0/45

Questionnaire Only

Serious: 0

Deaths: 0

Serious adverse events (1 terms)

Reaction	System	Treatment Arm	Control Arm	Questionnaire Only
Infection	Infections and infestations	—	—	—

Most-reported serious reactions: Infection.

Data from ClinicalTrials.gov NCT00504582 adverse events section.

Sponsor's own description

Primary Objective:

* To determine whether the use of a fibrin sealant applied to axillary soft tissues following node dissection can result in earlier drain removal.

Secondary Objectives:

* To determine the postoperative morbidity rate using fibrin sealant following axillary node dissection.
* To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model.
* To determine if serum levels, lymphatic fluids level, or cutaneous expression of vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3) correlates with nodal tumor burden or development of lymphedema in patients with melanoma.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.